Antibiotic Therapy for Early Onset Neonatal Sepsis

Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis

Sponsors

Lead Sponsor: Shandong University

Collaborator: Tianjin Central Hospital of Gynecology Obstetrics
Shandong Provincial Hospital
Qianfoshan Hospital

Source Shandong University
Brief Summary

Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

Overall Status Recruiting
Start Date May 2019
Completion Date December 2025
Primary Completion Date October 2025
Study Type Observational
Primary Outcome
Measure Time Frame
Treatment failure 72 hours after ending initial antibiotic therapy
Secondary Outcome
Measure Time Frame
Treatment duration Through study completion, an average of 3 days
Duration of hospitalization In the first month of patients' life
PD target Through study completion, an average of 3 days
White blood cell count Through study completion, an average of 3 days
Procalcitonin Through study completion, an average of 3 days
C-reactive protein Through study completion, an average of 3 days
Death In the first month of patients' life
Adverse events Through study completion, an average of 3 days
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin

Description: Efficacy and safety of antibiotics

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Age: postnatal age ≤ 72h;

- Meets NICE guidelines for using antibiotics to treat EONS;

- Azlocillin used as part of antimicrobial treatment;

- Parental written consent.

Exclusion Criteria:

- Expected survival time less than the treatment cycle;

- Major congenital malformations;

- Undergoing surgery within the first week of life;

- Receiving other systemic trial drug therapy;

- Other factors that the researcher considers unsuitable for inclusion.

Gender: All

Minimum Age: N/A

Maximum Age: 3 Days

Healthy Volunteers: No

Overall Contact

Last Name: Wei Zhao, Ph.D

Phone: 86053188383308

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Tianjin Central Hospital of Gynecology Obstetrics Xiuying Tian, bachelor 022-58287230 [email protected] Xiuying Tian, bachelor Sub-Investigator
Location Countries

China

Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Wei Zhao

Investigator Title: Head of department of clinical pharmacy and pharmacology

Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov